BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 2172270 · Received June 23, 2011

    Report

    Report Number
    1037905-2011-00427
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 24, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    GCA
    PMA / PMN Number
    K063677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE RETURNED EXTRACTION BALLOON CONFIRMED THE REPORT. THE BALLOON MATERIAL EXHIBITS A SPLIT; THIS WAS CONFIRMED THROUGH A VISUAL EXAMINATION. IT APPEARS THAT A SMALL PORTION, APPROX 3MM IN LENGTH, OF THE BALLOON MATERIAL IS MISSING FROM THE DISTAL END OF THE BALLOON. THE CONDITION OF THE BALLOON MATERIAL PROHIBITS BALLOON INFLATION AND DEVICE USAGE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCTS FROM THIS LOT REMAINED IN INVENTORY. CONCLUSION: THE INFO PROVIDED INDICATED THE BALLOON WAS NOT INFLATED PRIOR TO USE. A SPLIT OR RUPTURE IN THE BALLOON MATERIAL CAN OCCUR IF THE BALLOON WAS INFLATED IN EXCESS OF THE RECOMMENDED INFLATION VOLUME. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ATTACH THE ENCLOSED SYRINGE TO THE STOPCOCK (WHICH IS ATTACHED TO THE INFLATION PORT) TO INFLATE THE BALLOON. A SPLIT OR RUPTURE IN THE BALLOON MATERIAL CAN ALSO OCCUR IF ADDED PRESSURE WAS APPLIED DURING EXTRACTION. THE INSTRUCTIONS FOR USE DIRECT THE USER TO GENTLY WITHDRAW THE INFLATED BALLOON TOWARD THE PAPILLA. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING: "DO NOT EXERT EXCESSIVE PRESSURE ON AMPULLA WHILE EXTRACTING STONES. IF STONE DOES NOT PASS EASILY, REASSESS NEED FOR SPHINCTEROTOMY." PRIOR TO DISTRIBUTION, ALL FUSION QUATTRO EXTRACTION BALLOONS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES AN AIR INFLATION TEST TO ENSURE PROPER BALLOON FUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A BILE DUCT STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A FUSION QUATTRO EXTRACTION BALLOON. AFTER INFLATION THE BALLOON RUPTURED. THE PHYSICIAN INSERTED THE DEVICE TO BIFURCATION REA OF THE BILE DUCT TO CONDUCT THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION QUATTRO EXTRACTION BALLOON GCA, CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL, INC. W2973623

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS JF-260V ENDOSCOPE